Role of Epoxyeicosatrienoic Acids in Chronic Allograft Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Difference between patients with the EPHX2 Lys55Arg polymorphism and patients without in estimated Glomerular Filtration Rate (eGFR)
研究概览
简要总结
Endothelial lesions within the transplanted kidney are a major determinant of chronic allograft nephropathy. Epoxyeicosatrienoic acids (EETs) are endothelium-derived hyperpolarizing factors with anti-inflammatory, antiproliferative and vasodilator properties.
The main goal of the investigators' study is to evaluate whether genetic polymorphisms of specific enzymes responsible for the bioavailability of EETs are associated with post-transplant kidney function.
To this end, 80 kidney transplant recipients will be included. Prespecified genetic polymorphisms of CYP 2J2, CYP 2C8, CYP 2C9, CYP 2C9, CYP 2C19 and EPHX2 will be determined. Kidney function will be recorded 3, 6, 12 and 36 months after transplantation. Flow-mediated dilatation, EETs and circulating biomarkers of endothelial function will be measured in the radial artery.
The expected results of this study to provide preliminary evidence supporting a beneficial role of an increase in the bioavailability of EETs in kidney transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 to 75 yo
- •Caucasian (because of different CYP epoxygenase polymorphisms)
- •First kidney transplantation performed in Rouen University Hospital after 2000, and at least 12 months before inclusion
- •Patient having read, understood and approved the informed consent
- •Efficient contraception in child-bearing aged women
- •Regular health insurance
排除标准
- •Primary non-function, or allograft loss before 1 year
- •Previous kidney transplantation
- •History of psychiatric, psychologic or sensorial disorder preventing the patient from correctly understanding the protocol
- •History of bilateral arm or forearm arteriovenous fistula
- •Counter-indication to trinitrin
- •Insufficient understanding of written or spoken French language
- •Liberty-deprived patient
- •Pregnancy or absence of contraception in child-bearing aged women
- •Patient enrolled in another research protocol within 2 weeks before inclusion
研究组 & 干预措施
Kidney transplant recipients
blood sampling is done for determination of EPHX Lys55Arg and other polymorphisms status in Kidney transplant recipients.
flow-mediated distal stimulation of the forearm radial artery by cutaneous heating is assessed for evaluation of EEts level in Kidney transplant recipients.
干预措施: Blood sampling (Procedure)
Kidney transplant recipients
blood sampling is done for determination of EPHX Lys55Arg and other polymorphisms status in Kidney transplant recipients.
flow-mediated distal stimulation of the forearm radial artery by cutaneous heating is assessed for evaluation of EEts level in Kidney transplant recipients.
干预措施: flow-mediated distal stimulation of the forearm radial artery by cutaneous heating (Procedure)
结局指标
主要结局
Difference between patients with the EPHX2 Lys55Arg polymorphism and patients without in estimated Glomerular Filtration Rate (eGFR)
时间窗: 12 Months after transplantation
eGFR Scores range from 0 \[kidney failure\] to \>90 \[normal function\]
次要结局
- Difference between patients with the EPHX2 Lys55Arg polymorphism and patients without in estimated Glomerular Filtration Rate (eGFR)(3 Months after transplantation)
- Difference between patients with the EPHX2 Lys55Arg polymorphism and patients without in estimated Glomerular Filtration Rate (eGFR)(6 Months after transplantation)
- Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)(3 Months after transplantation)
- Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)(6 Months after transplantation)
- Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)(12 Months after transplantation)
- Difference between variation of diameter of the forearm radial artery after distal cutaneous heating for patients with the specified polymorphisms.(Day 1)
- Difference between patients with the EPHX2 Lys55Arg polymorphism and patients without in estimated Glomerular Filtration Rate (eGFR)(36 Months after transplantation)
- Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)(36 Months after transplantation)
- Difference between blood EETs concentration at baseline and after distal cutaneous heating for patients with the specified polymorphisms.(Day 1)
- Difference between blood EETs concentration at baseline and after distal cutaneous heating for patients without the specified polymorphisms.(Day 1)
- Difference between variation of diameter of the forearm radial artery after distal cutaneous heating for patients without the specified polymorphisms.(Day 1)